RP2D in Ph 1 Study of SENTI-202 for the Treatment of R/R Heme Malignancies, Including AML, Determined August 12, 2025
Approval of the third of four stages of the Ph 1/2 study of AB8939 in R/R AML patients announced August 5, 2025
Positive Data from Long-Term Follow-Up Analysis of the Ph 3 AGILE Trial of TIBSOVO® (ivosidenib) in IDH1-mutated AML Announced July 29, 2025
Aptose and Hanmi Enter New Loan Agreement to Advance Development of Tuspetinib in Triplet Therapy for AML July 23, 2025
All Primary Endpoints Met in Ph 2 Trial of SLS009 in R/R AML; FDA Guidance Received to Advance into 1L Therapy Study July 23, 2025
Supplemental NDA for INQOVI (decitabine & cedazuridine) + venetoclax for 1L AML adults ineligible for intensive induction chemo accepted by FDA July 15, 2025
FDA grants Priority Review to Supplemental NDA for Revuforj® (revumenib) in R/R mNPM1 AML; PDUFA action date Oct 2025 July 1, 2025
First Patient Completes DLT Observation Period with No Reported DLTs in Ph 1 Trial of CER-1236 June 24, 2025
FDA Accepts and grants Priority Review of NDA for Ziftomenib in Adults with R/R NPM1-Mutant AML June 3, 2025
EMA approves CTA to conduct pivotal Ph 2B/3 trial of Annamycin + cytarabine in R/R AML patients May 21, 2025
Tuspetinib-based Triplet regimen in 1L AML Patients in Ph 1/2 TUSCANY Trial Demonstrates Safety, Complete Remissions May 6, 2025
